Can we achieve better trial recruitment by presenting patient information through multimedia? Meta-analysis of 'studies within a trial' (SWATs).

BACKGROUND: People need high-quality information to make decisions about research participation. Providing information in written format alone is conventional but may not be the most effective and acceptable approach. We developed a structure for the presentation of information using multimedia which included generic and trial-specific content. Our aim was to embed 'Studies Within A Trial' (SWATs) across multiple ongoing trials to test whether multimedia presentation of patient information led to better rates of recruitment. METHODS: Five trials included a SWAT and randomised their participants to receive a multimedia presentation alongside standard information, or standard written information alone. We collected data on trial recruitment, acceptance and retention and analysed the pooled results using random effects meta-analysis, with the primary outcome defined as the proportion of participants randomised following an invitation to take part. RESULTS: Five SWATs provided data on the primary outcome of proportion of participants randomised. Multimedia alongside written information results in little or no difference in recruitment rates (pooled odds ratio = 0.96, 95% CI: 0.79 to 1.17, p-value = 0.671, I2 = 0%). There was no effect on any other outcomes. CONCLUSIONS: Multimedia alongside written information did not improve trial recruitment rates. TRIAL REGISTRATION: ISRCTN71952900, ISRCTN 06710391, ISRCTN 17160087, ISRCTN05926847, ISRCTN62869767.

Supported Intervention Versus Intervention Alone for Management of Fecal Incontinence in Patients With Inflammatory Bowel Disease: A Multicenter Mixed-Methods Randomized Controlled Trial.

PURPOSE: The aims of this study were to test a noninvasive self-management intervention supported by specialist nurses versus intervention alone in patients with inflammatory bowel disease (IBD) experiencing fecal incontinence and to conduct a qualitative evaluation of the trial. DESIGN: Multicenter, parallel-group, open-label, mixed-methods randomized controlled trial (RCT). SUBJECTS AND SETTING: The sample comprised patients from a preceding case-finding study who reported fecal incontinence and met study requirements; the RCT was delivered via IBD outpatient clinics in 6 hospitals (5 in major UK cities, 1 rural) between September 2015 and August 2017. Sixteen participants and 11 staff members were interviewed for qualitative evaluation. METHODS: Adults with IBD completed the study activities over a 3-month period following randomization. Each participant received either four 30-minute structured sessions with an IBD clinical nurse specialist and a self-management booklet or the booklet alone. Low retention numbers precluded statistical analysis; individual face-to-face or telephone interviews, recorded digitally and transcribed professionally, were conducted to evaluate the RCT. Transcripts were analyzed thematically using an inductive method. RESULTS: Sixty-seven participants (36%) of the targeted 186 participants were recruited. The groups comprised 32 participants (17% of targeted participants) allocated to the nurse + booklet intervention and 35 (18.8% of targeted participants) allocated to the booklet alone. Less than one-third (n = 21, 31.3%) completed the study. Given the low recruitment and high attrition, statistical analysis of quantitative data was considered futile. Participant interviews were conducted concerning study participation and 4 themes emerged that described experiences of patients and staff. These data provided insights into reasons for low recruitment and high attrition, as well as challenges of delivering resource-heavy studies in busy health service environments. CONCLUSIONS: Alternative approaches to trials of nurse-led interventions in hospital settings are needed as many interfering factors may prevent successful completion.

STOP- a training intervention to optimise treatment for smoking cessation in community pharmacies: cluster randomised controlled trial.

BACKGROUND: Community pharmacies serve people with high levels of tobacco-related illness, but throughput in NHS Stop Smoking Services in pharmacies remains relatively low. We investigated the effectiveness of a complex intervention to increase service uptake and retention. METHODS: We randomised 60 pharmacies in England and Wales to the STOP intervention or usual practice in a pragmatic, parallel-group, controlled trial over 11 months. Smokers were blind to the allocation. The intervention was theory-based consultation skills training for pharmacy staff with environmental prompts (badges, calendars and behavioural cues). The primary outcome was the number of smokers attending an initial consultation and setting a quit date. RESULTS: The intervention made no significant difference in setting a quit date, retention or quit rate. A total of 631 adult smokers (service users) enrolled and set a quit date in intervention pharmacies compared to 641 in usual practice pharmacies, a rate ratio of 0.75 (95% CI 0.46 to 1.23) adjusted for site and number of prescriptions. A total of 432 (68%) service users were retained at 4 weeks in intervention and 500 (78%) in usual practice pharmacies (odds ratio 0.80, 0.41 to 1.55). A total of 265 (42%) service users quit smoking at 4 weeks in intervention and 276 (43%) in usual practice pharmacies (0.96, 0.65 to 1.43). The pharmacy staff were positive about the intervention with 90% (56/62) stating that it had improved their skills. Sixty-eight per cent would strongly recommend the training to others although there was no difference in self-efficacy for service delivery between arms. Seventy of 131 (53%) service users did not complete the 6-month follow-up assessment. However, 55/61 (90%) service users who completed follow-up were satisfied or very satisfied with the service. All usual practice arm service users (n = 33) and all but one in the intervention arm (n = 27) would recommend the service to smokers. CONCLUSIONS: We found high levels of retention and acceptable quit rates in the NHS pharmacy stop smoking service. Despite pharmacy staff providing positive feedback on the STOP intervention, it made no difference to service throughput. Thus, other factors may currently limit service capacity to help smokers to quit. TRIAL REGISTRATION: ISRCTN, ISRCTN16351033 . Retrospectively registered.

Can we achieve better recruitment by providing better information? Meta-analysis of 'studies within a trial' (SWATs) of optimised participant information sheets.

BACKGROUND: The information given to people considering taking part in a trial needs to be easy to understand if those people are to become, and then remain, trial participants. However, there is a tension between providing comprehensive information and providing information that is comprehensible. User-testing is one method of developing better participant information, and there is evidence that user-tested information is better at informing participants about key issues relating to trials. However, it is not clear if user-testing also leads to changes in the rates of recruitment in trials, compared to standard trial information. As part of a programme of research, we embedded 'studies within a trial' (SWATs) across multiple ongoing trials to see if user-tested materials led to better rates of recruitment. METHODS: Seven 'host' trials included a SWAT evaluation and randomised their participants to receive routine information sheets generated by the research teams, or information sheets optimised through user-testing. We collected data on trial recruitment and analysed the results across these trials using random effects meta-analysis, with the primary outcome defined as the proportion of participants randomised in a host trial following an invitation to take part. RESULTS: Six SWATs (n=27,805) provided data on recruitment. Optimised participant information sheets likely result in little or no difference in recruitment rates (7.2% versus 6.8%, pooled odds ratio = 1.03, 95% CI 0.90 to 1.19, p-value = 0.63, I2 = 0%). CONCLUSIONS: Participant information sheets developed through user testing did not improve recruitment rates. The programme of work showed that co-ordinated testing of recruitment strategies using SWATs is feasible and can provide both definitive and timely evidence on the effectiveness of recruitment strategies. TRIAL REGISTRATION: Healthlines Depression (ISRCTN14172341) Healthlines CVD (ISRCTN27508731) CASPER (ISRCTN02202951) ISDR (ISRCTN87561257) ECLS (NCT01925625) REFORM (ISRCTN68240461) HeLP Diabetes (ISRCTN02123133).

Clinician Administered and Self-Report Survey Both Effective for Identifying Fecal Incontinence in Patients with Inflammatory Bowel Disease.

OBJECTIVES: To test two methods for reporting of fecal incontinence (FI) in people with inflammatory bowel disease. METHODS: Consecutive patients from IBD clinics in six UK hospitals completed a short three-item case-finding survey about FI; they either completed the survey themselves or were asked the same questions face to face by a clinician. RESULTS: Of 1336 eligible patients with complete data (48% male; mean 43 years; 55% Crohn's disease, 41% ulcerative colitis), 772 were asked about FI face to face, and 564 self-completed the survey: FI was reported in 63% and 56%, respectively (p = 0.012). In regression analyses, those aged 51-60, having Crohn's disease and higher disease activity, were more likely to report FI. Of all respondents, 38.7% were interested in receiving help for their incontinence. CONCLUSIONS: Fecal incontinence affects the majority of people with IBD. Although more patients reported fecal incontinence when asked face to face than self-reported, routine screening by either method in clinical practice is recommended. Over one-third of patients with IBD want help for bowel control problems.

Community pharmacy interventions for health promotion: effects on professional practice and health outcomes.

BACKGROUND: Community pharmacies are an easily accessible and cost-effective platform for delivering health care worldwide, and the range of services provided has undergone rapid expansion in recent years. Thus, in addition to dispensing medication, pharmacy workers within community pharmacies now give advice on a range of health-promoting behaviours that aim to improve health and to optimise the management of long-term conditions. However, it remains uncertain whether these health-promotion interventions can change the professional practice of pharmacy workers, improve health behaviours and outcomes for pharmacy users and have the potential to address health inequalities. OBJECTIVES: To assess the effectiveness and safety of health-promotion interventions to change community pharmacy workers' professional practice and improve outcomes for users of community pharmacies. SEARCH METHODS: We searched MEDLINE, Embase, CENTRAL, six other databases and two trials registers to 6 February 2018. We also conducted reference checking, citation searches and contacted study authors to identify any additional studies. SELECTION CRITERIA: We included randomised trials of health-promotion interventions in community pharmacies targeted at, or delivered by, pharmacy workers that aimed to improve the health-related behaviour of people attending the pharmacy compared to no treatment, or usual treatment received in the community pharmacy. We excluded interventions where there was no interaction between pharmacy workers and pharmacy users, and those that focused on medication use only. DATA COLLECTION AND ANALYSIS: We used standard procedures recommended by Cochrane and the Effective Practice and Organisation of Care review group for both data collection and analysis. We compared intervention to no intervention or to usual treatment using standardised mean differences (SMD) and 95% confidence intervals (95% CI) (higher scores represent better outcomes for pharmacy user health-related behaviour and quality of life, and lower scores represent better outcomes for clinical outcomes, costs and adverse events). Interpretation of effect sizes (SMD) was in line with Cochrane recommendations. MAIN RESULTS: We included 57 randomised trials with 16,220 participants, described in 83 reports. Forty-nine studies were conducted in high-income countries, and eight in middle-income countries. We found no studies that had been conducted in low-income countries. Most interventions were educational, or incorporated skills training. Interventions were directed at pharmacy workers (n = 8), pharmacy users (n = 13), or both (n = 36). The clinical areas most frequently studied were diabetes, hypertension, asthma, and modification of cardiovascular risk. Duration of follow-up of interventions was often unclear. Only five studies gave details about the theoretical basis for the intervention, and studies did not provide sufficient data to comment on health inequalities. The most common sources of bias were lack of protection against contamination - mainly in individually randomised studies - and inadequate blinding of participants. The certainty of the evidence for all outcomes was moderate. We downgraded the certainty because of the heterogeneity across studies and evidence of potential publication bias. Professional practice outcomes We conducted a narrative analysis for pharmacy worker behaviour due to high heterogeneity in the results. Health-promotion interventions probably improve pharmacy workers' behaviour (2944 participants; 9 studies; moderate-certainty evidence) when compared to no intervention. These studies typically assessed behaviour using a simulated patient (mystery shopper) methodology. Pharmacy user outcomes Health-promotion interventions probably lead to a slight improvement in health-related behaviours of pharmacy users when compared to usual treatment (SMD 0.43, 95% CI 0.14 to 0.72; I2 = 89%; 10 trials; 2138 participants; moderate-certainty evidence). These interventions probably also lead to a slight improvement in intermediate clinical outcomes, such as levels of cholesterol or glycated haemoglobin, for pharmacy users (SMD -0.43, 95% CI -0.65 to -0.21; I2 = 90%; 20 trials; 3971 participants; moderate-certainty evidence). We identified no studies that evaluated the impact of health-promotion interventions on event-based clinical outcomes, such as stroke or myocardial infarction, or the psychological well-being of pharmacy users. Health-promotion interventions probably lead to a slight improvement in quality of life for pharmacy users (SMD 0.29, 95% CI 0.08 to 0.50; I2= 82%; 10 trials, 2687 participants; moderate-certainty evidence). Adverse events No studies reported adverse events for either pharmacy workers or pharmacy users. Costs We found that health-promotion interventions are likely to be cost-effective, based on moderate-certainty evidence from five of seven studies that reported an economic evaluation. AUTHORS' CONCLUSIONS: Health-promotion interventions in the community pharmacy context probably improve pharmacy workers' behaviour and probably have a slight beneficial effect on health-related behaviour, intermediate clinical outcomes, and quality of life for pharmacy users. Such interventions are likely to be cost-effective and the effects are seen across a range of clinical conditions and health-related behaviours. Nevertheless the magnitude of the effects varies between conditions, and more effective interventions might be developed if greater consideration were given to the theoretical basis of the intervention and mechanisms for effecting behaviour change.

Sequence balance minimisation: minimising with unequal treatment allocations.

BACKGROUND: Minimisation ensures excellent balance between groups for several prognostic factors, even in small samples. However, its use with unequal allocation ratios has been problematic. This paper describes a new minimisation scheme named sequence balance minimisation for unequal treatment allocations. METHODS: Treatment- and factor-balancing properties were assessed in simulation studies for two- and three-arm trials with 1:2 and 1:2:3 allocation ratios. Sample sizes were set 30, 60 and 120. The number of prognostic factors on which to achieve balance was ranged from zero (treatment totals only) to ten with two levels occurring in equal probabilities. Random elements were set at 0.95, 0.9, 0.85, 0.80, 0.7, 0.6 and 0.5. Characteristics of the randomisation distributions and the impact of changing the block size while maintaining the allocation ratio were also examined. RESULTS: Sequence balance minimisation has good treatment- and factor-balancing capabilities, and the randomisation distribution was centred at zero for all scenarios. The mean and median number of allocations achieved were the same as the number expected in most scenarios, and including additional factors (up to ten) in the minimisation scheme had little impact on treatment balance. Treatment balance tended to depart from the target as the random element was lowered. The variability in allocations achieved increased slightly as the number of factors increased, as the random element was decreased and as the sample size increased. The mean and median factor imbalance remained tightly around zero even when the chosen factor was not included in the minimisation scheme, though the variability was greater. The variability in factor imbalance increased slightly as the random element decreased, as well as when the number of prognostic factors and sample size increased. Increasing block size while maintaining the allocation ratio improved treatment balance notably with little impact on factor imbalance. CONCLUSIONS: Sequence balance minimisation has good treatment- and factor-balancing properties and is particularly useful for small trials seeking to achieve balance across several prognostic factors.

An optimised patient information sheet did not significantly increase recruitment or retention in a falls prevention study: an embedded randomised recruitment trial.

BACKGROUND: Randomised controlled trials are generally regarded as the 'gold standard' experimental design to determine the effectiveness of an intervention. Unfortunately, many trials either fail to recruit sufficient numbers of participants, or recruitment takes longer than anticipated. The current embedded trial evaluates the effectiveness of optimised patient information sheets on recruitment of participants in a falls prevention trial. METHODS: A three-arm, embedded randomised methodology trial was conducted within the National Institute for Health Research-funded REducing Falls with ORthoses and a Multifaceted podiatry intervention (REFORM) cohort randomised controlled trial. Routine National Health Service podiatry patients over the age of 65 were randomised to receive either the control patient information sheet (PIS) for the host trial or one of two optimised versions, a bespoke user-tested PIS or a template-developed PIS. The primary outcome was the proportion of patients in each group who went on to be randomised to the host trial. RESULTS: Six thousand and nine hundred patients were randomised 1:1:1 into the embedded trial. A total of 193 (2.8%) went on to be randomised into the main REFORM trial (control n = 62, template-developed n = 68; bespoke user-tested n = 63). Information sheet allocation did not improve recruitment to the trial (odds ratios for the three pairwise comparisons: template vs control 1.10 (95% CI 0.77-1.56, p = 0.60); user-tested vs control 1.01 (95% CI 0.71-1.45, p = 0.94); and user-tested vs template 0.92 (95% CI 0.65-1.31, p = 0.65)). CONCLUSIONS: This embedded methodology trial has demonstrated limited evidence as to the benefit of using optimised information materials on recruitment and retention rates in the REFORM study. TRIAL REGISTRATION: International Standard Randomised Controlled Trials Number registry, ISRCTN68240461 . Registered on 01 July 2011.

Guidelines for reporting embedded recruitment trials.

BACKGROUND: Recruitment to clinical trials is difficult with many trials failing to recruit to target and within time. Embedding trials of recruitment interventions within host trials may provide a successful way to improve this. There are no guidelines for reporting such embedded methodology trials. As part of the Medical Research Council funded Systematic Techniques for Assisting Recruitment to Trials (MRC START) programme designed to test interventions to improve recruitment to trials, we developed guidelines for reporting embedded trials. METHODS: We followed a three-phase guideline development process: (1) pre-meeting literature review to generate items for the reporting guidelines; (2) face-to-face consensus meetings to draft the reporting guidelines; and (3) post-meeting feedback review, and pilot testing, followed by finalisation of the reporting guidelines. RESULTS: We developed a reporting checklist based on the Consolidated Standards for Reporting Trials (CONSORT) statement 2010. Embedded trials evaluating recruitment interventions should follow the CONSORT statement 2010 and report all items listed as essential. We used a number of examples to illustrate key issues that arise in embedded trials and how best to report them, including (a) how to deal with description of the host trial; (b) the importance of describing items that may differ in the host and embedded trials (such as the setting and the eligible population); and (c) the importance of identifying clearly the point at which the recruitment interventions were embedded in the host trial. CONCLUSIONS: Implementation of these guidelines will improve the quality of reports of embedded recruitment trials while advancing the science, design and conduct of embedded trials as a whole.